title: An automated database case definition for serious bleeding related to oral anticoagulant use.
abstract: OBJECTIVE
  Bleeding complications are a serious adverse effect of medications that prevent abnormal blood clotting. To facilitate epidemiologic investigations of bleeding complications, we developed and validated an automated database case definition for bleeding-related hospitalizations.
  
  
  METHODS
  The case definition utilized information from an in-progress retrospective cohort study of warfarin-related bleeding in Tennessee Medicaid enrollees 30 years of age or older. It identified inpatient stays during the study period of January 1990 to December 2005 with diagnoses and/or procedures that indicated a current episode of bleeding. The definition was validated by medical record review for a sample of 236 hospitalizations.
  
  
  RESULTS
  We reviewed 186 hospitalizations that had medical records with sufficient information for adjudication. Of these, 165 (89%, 95%CI: 83-92%) were clinically confirmed bleeding-related hospitalizations. An additional 19 hospitalizations (10%, 7-15%) were adjudicated as possibly bleeding-related. Of the 165 clinically confirmed bleeding-related hospitalizations, the automated database and clinical definitions had concordant anatomical sites (gastrointestinal, cerebral, genitourinary, other) for 163 (99%, 96-100%). For those hospitalizations with sufficient information to distinguish between upper/lower gastrointestinal bleeding, the concordance was 89% (76-96%) for upper gastrointestinal sites and 91% (77-97%) for lower gastrointestinal sites.
  
  
  CONCLUSIONS
  A case definition for bleeding-related hospitalizations suitable for automated databases had a positive predictive value of between 89% and 99% and could distinguish specific bleeding sites.
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, Nashville, TN, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Cunningham
authors.forename: C Michael
authors.initials: CM
authors.lastname: Stein
authors.forename: Cecilia P
authors.initials: CP
authors.lastname: Chung
authors.forename: James R
authors.initials: JR
authors.lastname: Daugherty
authors.forename: Walter E
authors.initials: WE
authors.lastname: Smalley
authors.forename: Wayne A
authors.initials: WA
authors.lastname: Ray
mesh_terms: D000328:Adult; D000925:Anticoagulants / Q000009:adverse effects*; D001331:Automation; D015331:Cohort Studies; D016208:Databases, Factual; D004812:Epidemiologic Methods; D006470:Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008484:Medicaid; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013714:Tennessee; D014481:United States; D014859:Warfarin / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D014859:Warfarin